Cleared Traditional

EM-07 Cordless Endo Motor (K232551) - FDA 510(k) Clearance

Class I Dental device.

K232551 · Forum Engineering Technologies (96) , Ltd. · Dental device
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Jul 2024
Decision
321d
Days
Class 1
Risk

K232551 is an FDA 510(k) clearance for the EM-07 Cordless Endo Motor. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Forum Engineering Technologies (96) , Ltd. (Ashkelon, IL). The FDA issued a Cleared decision on July 9, 2024 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Forum Engineering Technologies (96) , Ltd. devices

Submission Details

510(k) Number K232551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2023
Decision Date July 09, 2024
Days to Decision 321 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 127d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 28
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K232551.
HPR Cordless Hygiene Handpiece
K243911 · Handpiece Headquarters · Dec 2024
The Trust
K222688 · Genoss Co., Ltd. · Aug 2024
X-Smart Pro
K233865 · Dentsply Sirona, Inc. · Jul 2024
Dental Handpiece, Wireless Endodontic Handpiece, endoit
K232810 · Micro-Nx Co., Ltd. · Nov 2023
InnerView LC
K232657 · Perimetrics, Inc. · Sep 2023
Endo Motor
K220829 · Foshan Coxo Medical Instrument Co., Ltd. · May 2023